Nutritional Approaches in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ketogenic diet
Intermittent therapeutical fasting
Active comparator
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis focused on measuring Relapse-remitting Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Existing health insurance, so that in case of random findings these can also be clarified
- Patients with relapsed-remitting MS according to the MS diagnostic criteria according to McDonald 2010
- Age 18-65
- Consent ability and written consent
- BMI between 19 and 45 kg / m2
- EDSS <4.5
- Stable immunomodulatory therapy or no immunomodulatory therapy> 6 months before confinement
- In the last 2 years ≥ 1 relapse or within the last 2 years ≥ 1 new T2 lesions or ≥ 1 contrast-sensitive lesion in MRT
- Consent that possible random findings are reported
Exclusion Criteria:
- Initiation or modification of immunomodulatory therapy during the study
- Cortisone treatment in the last 30 days before enrollment
- Relapse in the last 30 days before enrollment
- Insulin-dependent diabetes mellitus (type I)
- Intake of Omega 3 fatty acids (DHA, EPA) - more than 1 g / day
- Significant cognitive impairment, clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study
- Malignant disease
- Simultaneous participation in an interventional study or participation in an interventional study in the last two months before study inclusion
- Clinically relevant addiction or substance abuse disorder (defined as alcohol, drug and drug abuse)
- Nicotine consumption of > 5 cigarettes per day and no willingness to stop consumption during therapeutic fasting.
- Insufficient mental possibility of cooperation
- Eating disorder
- Kidney stones
- Known metabolic disorders (e.g., fatty acid oxidation disorders, ketolysis / ketogenesis or glucogenesis disorder, hyperinsulinism (e.g., nesidioblastoma), pyruvate carboxylase deficiency)
- Therapy with oral anticoagulants (e.g., Marcumar)
- Pregnancy and breast feeding period
- Suspected lack of compliance
- Performing of a diet for weight reduction
- Special diet for medical reasons
- Change of the body weight of more than 5 kg within one month before the start of the Intervention
- Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study
- Contraindications to MRT examinations [persons with metallic implants (e.g., intracranial metal clips) and carriers of electronic devices (e.g., pacemaker) or persons with claustrophobia]
Sites / Locations
- Charité - Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Ketogenic diet
Intermittent therapeutical fasting
Control group
Arm Description
The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients.
Outcomes
Primary Outcome Measures
Change in cerebral T2 lesions from Baseline at 18 months
Number of new cerebral T2 lesions in MRT after 18 months compared to baseline MRT
Secondary Outcome Measures
Change in neurological-functional disability: physical and cognitive function
influence of the interventions on cognitive and physical disability progression using Multiple Sclerosis Functional Composite (MSFC)
Change in neurological-functional disability : physical function
influence of the interventions on physical disability progression using Expanded Disability Status Score (EDSS). The EDSS is assessing the progress of disability in MS patients with a scale between 0-12 points, while 0 indicates no disability and 10 indicates death through MS.
annual relapse rate
relapse rate
progress of brain atrophy
PBVC = percent brain volume change
Full Information
NCT ID
NCT03508414
First Posted
December 21, 2017
Last Updated
July 28, 2021
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT03508414
Brief Title
Nutritional Approaches in Multiple Sclerosis
Official Title
Nutritional Approaches in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this project is to characterize the influence of a ketogenic diet and intermittent therapeutical fasting on the course of the disease, as measured by T2-hyperintense cerebral lesions with magnetic resonance tomography (MRT) in patients with multiple sclerosis (RRMS). The investigators expect in both intervention groups fewer cerebral T2 lesions occurring after 18 months in comparison to the control group and as detectable by MRT. According to current recommendations of the German Society of Nutrition (DGE), the control group receives a vegetarian-focused, anti-inflammatory diet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Relapse-remitting Multiple Sclerosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketogenic diet
Arm Type
Experimental
Arm Title
Intermittent therapeutical fasting
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients.
Intervention Type
Behavioral
Intervention Name(s)
ketogenic diet
Intervention Description
Patients receive a ketogenic diet, which is carbohydrate-reduced with a high amount of fat.
Intervention Type
Behavioral
Intervention Name(s)
Intermittent therapeutical fasting
Intervention Description
Patients fast for 1 week every six months. Additionally, the patients do an intermittent fasting, that is to say they do not eat for at least 14 hours a day.
Intervention Type
Behavioral
Intervention Name(s)
Active comparator
Intervention Description
The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients.
Primary Outcome Measure Information:
Title
Change in cerebral T2 lesions from Baseline at 18 months
Description
Number of new cerebral T2 lesions in MRT after 18 months compared to baseline MRT
Time Frame
Change from baseline at 18 months
Secondary Outcome Measure Information:
Title
Change in neurological-functional disability: physical and cognitive function
Description
influence of the interventions on cognitive and physical disability progression using Multiple Sclerosis Functional Composite (MSFC)
Time Frame
Change from baseline at 9 and 18 months
Title
Change in neurological-functional disability : physical function
Description
influence of the interventions on physical disability progression using Expanded Disability Status Score (EDSS). The EDSS is assessing the progress of disability in MS patients with a scale between 0-12 points, while 0 indicates no disability and 10 indicates death through MS.
Time Frame
Change from baseline at 9 and 18 months
Title
annual relapse rate
Description
relapse rate
Time Frame
12 months
Title
progress of brain atrophy
Description
PBVC = percent brain volume change
Time Frame
Change from baseline at 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Existing health insurance, so that in case of random findings these can also be clarified
Patients with relapsed-remitting MS according to the MS diagnostic criteria according to McDonald 2010
Age 18-65
Consent ability and written consent
BMI between 19 and 45 kg / m2
EDSS <4.5
Stable immunomodulatory therapy or no immunomodulatory therapy> 6 months before confinement
In the last 2 years ≥ 1 relapse or within the last 2 years ≥ 1 new T2 lesions or ≥ 1 contrast-sensitive lesion in MRT
Consent that possible random findings are reported
Exclusion Criteria:
Initiation or modification of immunomodulatory therapy during the study
Cortisone treatment in the last 30 days before enrollment
Relapse in the last 30 days before enrollment
Insulin-dependent diabetes mellitus (type I)
Intake of Omega 3 fatty acids (DHA, EPA) - more than 1 g / day
Significant cognitive impairment, clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study
Malignant disease
Simultaneous participation in an interventional study or participation in an interventional study in the last two months before study inclusion
Clinically relevant addiction or substance abuse disorder (defined as alcohol, drug and drug abuse)
Nicotine consumption of > 5 cigarettes per day and no willingness to stop consumption during therapeutic fasting.
Insufficient mental possibility of cooperation
Eating disorder
Kidney stones
Known metabolic disorders (e.g., fatty acid oxidation disorders, ketolysis / ketogenesis or glucogenesis disorder, hyperinsulinism (e.g., nesidioblastoma), pyruvate carboxylase deficiency)
Therapy with oral anticoagulants (e.g., Marcumar)
Pregnancy and breast feeding period
Suspected lack of compliance
Performing of a diet for weight reduction
Special diet for medical reasons
Change of the body weight of more than 5 kg within one month before the start of the Intervention
Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study
Contraindications to MRT examinations [persons with metallic implants (e.g., intracranial metal clips) and carriers of electronic devices (e.g., pacemaker) or persons with claustrophobia]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedemann Paul, Dr. med.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31898518
Citation
Bahr LS, Bock M, Liebscher D, Bellmann-Strobl J, Franz L, Pruss A, Schumann D, Piper SK, Kessler CS, Steckhan N, Michalsen A, Paul F, Mahler A. Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study. Trials. 2020 Jan 2;21(1):3. doi: 10.1186/s13063-019-3928-9.
Results Reference
derived
Learn more about this trial
Nutritional Approaches in Multiple Sclerosis
We'll reach out to this number within 24 hrs